5 Questions on Regulatory Expectations for Management with Larry Spears

Larry Spears is director, Health Sciences Industry, Deloitte and Touche, LLP and former CDRH Deputy Director for Regulatory Affairs. We asked him to draw on his 30 years of experience to explain exactly what role managers take in the regulatory process.

Larry Spears

What is the role of the management representative in an effective quality system?

The representative should be a key player in developing the firm’s quality policy and in assuring that it is followed. That individual should participate regularly in management reviews. The management representative also needs to have sufficient delegated authority and responsibility for ensuring the following:

Adequate resources are available

All employees are appropriately trained

Operations are monitored and changes are suggested, as appropriate

Regular review and reporting on the performance of the quality system

What should executive management be looking at during management reviews?
First and foremost, they need to be determining whether their operations are being performed in accordance with the firm’s quality policy and the quality system regulation, 21 CFR Part 820. This includes the need to consider:

The adequacy of SOPs

The sufficiency of resources

The sources of quality data and problems

Documentation of the results of quality system reviews

What should the role of the president be in an FDA inspection?
The president or most responsible management authority (MRMA) at the firm should ensure that representatives from Regulatory Affairs and/or Quality Assurance:

Identify the scope of the inspection

Monitor the inspection on a daily basis

Receive inspection progress reports from the FDA investigator

Provide appropriate responses to investigator questions

Document investigator observations/concerns (whether or not on the FDA 483)

Additionally, the President or MRMA should be available, if possible, to receive the 483 and participate in the inspection closeout discussion.
Why does FDA address warning letters to the president or MRMA of a firm?
FDA does this to demonstrate the accountability of such officials for ensuring that regulatory requirements are met and that violations are corrected. The Agency also establishes effective prior notice for a possible follow-up regulatory action by issuing warning letters in this manner.
What effect does a warning letter have on a company's operations?
The impact on a company’s operations can be very significant. Within the company, it typically generates considerable activity to evaluate FDA’s cited violations and determine whether to correct or refute them. This oftentimes results in the submission of a written response and it may lead to increased resources to address the violations. Warning letters are posted on FDA’s website and the public nature of such letters can cause modification or termination of contracts, reduction in sales, reduction in stock values, and personnel changes in management and staff.. Significant changes that often occur include sales in management and staff at the firm.

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Larry Spears is a Director in the Deloitte Health Sciences Industry, Enterprise Risk Services/Life Sciences Regulatory group, where he provides advisory and consultative services to medical device companies on quality system development and remediation for FDA regulatory actions. Larry has over 30 years with the Food and Drug Administration as an investigator, compliance officer and compliance manager. He worked for FDA for over 25 years in the medical device area, where he gained considerable experience in quality systems inspection assessment, recalls, regulatory case management, and compliance and enforcement strategy development. He served as the Deputy Director for Regulatory Affairs for 8 years where he provided daily oversight on regulatory, compliance and enforcement decisions affecting the medical device industry.